BioPharm International Editors

Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.

Merck relaunches brand identity to reflect transformation into a science and technology company.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

Avantor released a packaging platform that allows for the direct dispensing of chemicals-such as salts, buffers, and cell culture ingredients-into processing equipment.

The process provides an alternative to the sterilization of cartridges and vials with ethylene oxide (EtO).

Hiroaki Suzuki will lead Vetter’s business activities in the new Tokyo-based office.

Althea is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.

Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.

The company presented a portfolio of new products during the meeting in Madrid.

The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.

A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.

A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.

Biogen, Sobi, and the World Federation of Hemophilia collaborated to enable a sustained humanitarian supply of hemophilia treatment to developing countries, and the first shipments have begun to arrive.

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

The Bothell, WA location will help the company reach its goal of expanding its global capacity by more than 30,000 liters.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.

Merck Millipore’s collaboration with celares GmbH launches pegylation services for protein-based therapeutics.

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

The National Biologics Manufacturing Centre will provide companies with open access to bioprocessing facilities and expertise to expedite low-risk market entry of complex biologics.

The project seeks to index the properties of various proteins in solution and create a home for data on the performance of product excipients with their active substances.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

Pharma development and manufacturing firm Patheon announces new tagline and logo.

Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.